Latest Posts › Artificial Intelligence

Share:

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

CDRH Looks Ahead With FY 2025 Proposed Guidance Agenda

On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in the 2025 fiscal year (FY)....more

Real-World Data Back in the Spotlight at FDA

On July 25, 2024, the US Food and Drug Administration (FDA) announced the release of a final version of its Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making...more

Key Takeaways | Medical Communications and Market Access

During this session, the panelists discussed medical communications and market access with a particular focus on commercialization. The discussion focused on how firms are leveraging technology and AI to build brands, drive...more

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

International News: Spotlight on Innovation - Issue 60

Innovation fuels business growth and ushers in success, yet it brings its own set of challenges. In our latest issue, we explore innovative products and processes including: - The EU’s new Unified Patent Court...more

FDA Charts Course for Regulating AI Used in Medical Products

On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,”...more

7 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide